API for the Exchange of Medicinal Product Information (APIX)
0.1.0 - ci-build International flag

API for the Exchange of Medicinal Product Information (APIX), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/APIX---API-Exchange-for-Medicinal-Products/ and changes regularly. See the Directory of published versions

ValueSet: APIX CTD/eCTD Section Code System

Official URL: http://hl7.org/fhir/uv/apix/ValueSet/apix-ctd-section-vs Version: 0.1.0
Standards status: Trial-use Active as of 2026-03-18 Maturity Level: 1 Computable Name: APIXCTDSectionVS

Value set for CTD section codes used in APIX regulatory submissions

References

Logical Definition (CLD)

Language: en

This value set includes codes based on the following rules:

 

Expansion

Expansion performed internally based on codesystem APIX CTD/eCTD Section Code System v0.1.0 (CodeSystem)

This value set contains 47 concepts

SystemCodeDisplay (en)DefinitionJSONXML
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  1.0Cover LetterCover Letter
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  1.2Administrative InformationAdministrative Information
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  1.3.1SPC, Labelling and Package LeafletSPC, Labelling and Package Leaflet
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  1.3.2Mock-upsMock-ups
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  1.3.3SpecimensSpecimens
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  1.4Information about the ExpertsInformation about the Experts
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  1.8.1Risk Management PlanRisk Management Plan
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  1.9Pharmacovigilance SystemPharmacovigilance System
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  2.2IntroductionIntroduction
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  2.3Quality Overall SummaryQuality Overall Summary
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  2.4Nonclinical OverviewNonclinical Overview
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  2.5Clinical OverviewClinical Overview
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  2.6Nonclinical SummaryNonclinical Summary
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  2.7Clinical SummaryClinical Summary
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  3.2.S.1General Information (Drug Substance)General Information (Drug Substance)
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  3.2.S.1.1NomenclatureNomenclature
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  3.2.S.1.2StructureStructure
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  3.2.S.1.3General PropertiesGeneral Properties
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  3.2.S.2Manufacture (Drug Substance)Manufacture (Drug Substance)
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  3.2.S.3Characterisation (Drug Substance)Characterisation (Drug Substance)
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  3.2.S.4Control of Drug SubstanceControl of Drug Substance
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  3.2.S.5Reference Standards or MaterialsReference Standards or Materials
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  3.2.S.6Container Closure SystemContainer Closure System
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  3.2.S.7Stability (Drug Substance)Stability (Drug Substance)
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  3.2.P.1Description and Composition of the Drug ProductDescription and Composition of the Drug Product
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  3.2.P.2Pharmaceutical DevelopmentPharmaceutical Development
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  3.2.P.3Manufacture (Drug Product)Manufacture (Drug Product)
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  3.2.P.4Control of ExcipientsControl of Excipients
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  3.2.P.5Control of Drug ProductControl of Drug Product
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  3.2.P.5.1Specification(s)Specification(s)
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  3.2.P.5.6Justification of Specification(s)Justification of Specification(s)
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  3.2.P.8Stability (Drug Product)Stability (Drug Product)
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  3.2.P.8.1Stability Summary and ConclusionStability Summary and Conclusion
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  3.2.P.8.2Post-approval Stability Protocol and CommitmentPost-approval Stability Protocol and Commitment
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  3.2.P.8.3Stability DataStability Data
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  3.2.A.1Facilities and EquipmentFacilities and Equipment
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  3.2.A.2Adventitious Agents Safety EvaluationAdventitious Agents Safety Evaluation
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  3.2.A.3ExcipientsExcipients
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  3.2.RRegional InformationRegional Information
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  4.1Table of Contents (Nonclinical)Table of Contents (Nonclinical)
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  4.2Study Reports (Nonclinical)Study Reports (Nonclinical)
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  5.1Table of Contents (Clinical)Table of Contents (Clinical)
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  5.2Tabular Listing of All Clinical StudiesTabular Listing of All Clinical Studies
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  5.3Clinical Study ReportsClinical Study Reports
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  5.3.5Reports of Efficacy and Safety StudiesReports of Efficacy and Safety Studies
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  5.3.5.1Study Reports of Controlled Clinical StudiesStudy Reports of Controlled Clinical Studies
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  5.3.5.3Reports of Analysis of Data from More than One StudyReports of Analysis of Data from More than One Study

Description of the above table(s).